iUni G2+ Prospective Study

Terminated

• Conditions: Knee Osteoarthritis

• Registration Number: NCT01820676
• Lead Sponsor: Restor3D

Brief Summary

This study is designed to monitor long term clinical outcomes of the iUni G2+ unicompartmental knee replacement

Detailed Description

The study subjects will be followed for 10 years post implant. The follow-up visit schedule will include visits at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post implant.

Study Timeline

• Study First Submitted: 2013-03-26
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-29
• Study Start: 2013-07-15
• Primary Completion: 2017-07-01
• Study Completion: 2022-10-14
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Clinical condition included in the approved Indications For Use
• Unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment
• Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
• > 18 years of age

Exclusion Criteria

• Simultaneous bilateral procedure required
• BMI > 35
• Treatment for cancer within the past 5 years, with the exception of skin cancer
• Poorly controlled diabetes
• Neuromuscular conditions which prevent patient from participating in study activities
• Active local or systemic infection
• Immunocompromised
• Fibromyalgia or other general body pain related condition
• Advanced tricompartmental osteoarthritis
• Symptomatic patellofemoral disease
• Rheumatoid arthritis or other forms of inflammatory joint disease (excluding Gout unless it is in the treated knee or limiting overall function)
• Loss of bone or musculature, osteoporosis, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified. Osteoporosis is defined by more than -2.5 standard deviations from the T score as measured on a Dual Energy X-Ray Absortiometry Scan (DEXA) within 2 years of surgery.
• Advanced loss of osteochondral structure on the affected femoral condyle
• Compromised ACL, PCL or collateral ligament
• Severe (>15º) fixed valgus or varus deformity
• Extension deficit > 15 º
• Prior history of failed implant surgery of the joint to be treated
• Unwilling or unable to comply with study requirements
• Participation in another clinical study which would confound results

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
KOOS Score	1 Year
Oxford Knee Score	1 Year
2011 Knee Society Score	1 Year

Trial Locations

Locations (1)

The London Clinic; 🇬🇧 London, United Kingdom